Financial And Insurance Assistance
If you need financial support to pay for Prolia, or if you need help understanding your insurance coverage, help is available.
Amgen, the manufacturer of Prolia, offers ways to help lower the cost of Prolia. For example, if you have commercial insurance, the Prolia Co-pay Program may help reduce the cost of your prescription. And if you dont have insurance coverage, you may find cost assistance through the Amgen Safety Net Foundation.
For more information on these programs, and to find out if youre eligible for support, visit the manufacturers website.
What Other Information Should I Know
Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests to be sure it is safe for you to receive denosumab injection and to check your body’s response to denosumab injection.
Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Treatment To Increase Bone Mass In Men With Osteoporosis
The efficacy and safety of Prolia in the treatment to increase bone mass in men with osteoporosis was demonstrated in a 1-year, randomized, double-blind, placebo-controlled trial. Enrolled men had a baseline BMD T-score between -2.0 and -3.5 at the lumbar spine or femoral neck. Men with a BMD T-score between -1.0 and -3.5 at the lumbar spine or femoral neck were also enrolled if there was a history of prior fragility fracture. Men with other diseases or on therapies that may affect bone were excluded from this study. The 242 men enrolled in the study ranged in age from 31 to 84 years with a mean age of 65 years. Men were randomized to receive SC injections of either placebo or Prolia 60 mg once every 6 months. All men received at least 1000 mg calcium and at least 800 IU vitamin D supplementation daily.
Effect on Bone Mineral Density The primary efficacy variable was percent change in lumbar spine BMD from baseline to 1 year. Secondary efficacy variables included percent change in total hip, and femoral neck BMD from baseline to 1 year.
Treatment with Prolia significantly increased BMD at 1 year. The treatment differences in BMD at 1 year were 4.8% p < 0.0001) at the lumbar spine, 2.0% at the total hip, and 2.2% at femoral neck. Consistent effects on BMD were observed at the lumbar spine regardless of baseline age, race, BMD, testosterone concentrations, and level of bone turnover.
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What Should I Know About Storage And Disposal Of This Medication
Keep this medication in the container it came in, tightly closed, and out of reach of children. Do not shake denosumab injection. Store it in the refrigerator and protect it from light. Do not freeze. Denosumab injection can be kept at room temperature for up to 14 days.
Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA’s Safe Disposal of Medicines website for more information if you do not have access to a take-back program.
It is important to keep all medication out of sight and reach of children as many containers are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location â one that is up and away and out of their sight and reach.
Doctors Support The Change
Richard Watkins, MD, an infectious disease physician and a professor of internal medicine at the Northeast Ohio Medical University, tells Verywell that there was never any compelling evidence for the previous recommendation, adding, I am glad it has been changed.
Watkins says that the move may help more children get vaccinated, noting the convenience factor. Under the updated guidance, families only have to make one trip to get vaccinated instead of several under the previous recommendations, he says.
John Schreiber, MD, a pediatric infectious disease specialist at Connecticut Children’s Medical Center, tells Verywell that the changed guidance seems like a reasonable thing to do.
Schreiber anticipates that some parents may still be wary to give their children other vaccines at the same time as the COVID-19 vaccine, but say that new recommendations are sound.
I dont have any concerns with this, Schreiber says. But, he adds, the CDC and AAP will monitor children to see what happens next. If it turns out that children are complaining about more side effects after getting vaccinated, Im sure the recommendations can be modified.”
The information in this article is current as of the date listed, which means newer information may be available when you read this. For the most recent updates on COVID-19, visit our coronavirus news page.
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Prolia Contraindications Pregnancy Safety And Drug Interactions
Do not take Prolia if you:
- have been told by your doctor that your blood calcium level is too low.
- are pregnant or plan to become pregnant.
- are allergic to denosumab or any of the ingredients in Prolia. See the end of this Medication Guide for a complete list of ingredients in Prolia.
Before taking Prolia, tell your doctor about all of your medical conditions, including if you:
- are taking a medicine called Xgeva . Xgeva contains the same medicine as Prolia.
- have low blood calcium.
- cannot take daily calcium and vitamin D.
- had parathyroid or thyroid surgery .
- have been told you have trouble absorbing minerals in your stomach or intestines .
- have kidney problems or are on kidney dialysis.
- are taking medicine that can lower your blood calcium levels.
- plan to have dental surgery or teeth removed.
- are pregnant or plan to become pregnant. Prolia may harm your unborn baby.
Females who are able to become pregnant:
- Your healthcare provider should do a pregnancy test before you start treatment with Prolia.
- You should use an effective method of birth control during treatment with Prolia and for at least 5 months after your last dose of Prolia.
- Tell your doctor right away if you become pregnant while taking Prolia.
Treatment Of Postmenopausal Women With Osteoporosis At High Risk For Fracture
Prolia is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, Prolia reduces the incidence of vertebral, nonvertebral, and hip fractures .
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Who Should Not Be Vaccinated
CDC recommends use of the flu shot and the recombinant influenza vaccine . The nasal spray flu vaccine should not be used during 2016-2017. Different flu vaccines are approved for use in different groups of people. Factors that can determine a persons suitability for vaccination, or vaccination with a particular vaccine, include a persons age, health and any allergies to flu vaccine or its components.
Can I Have The Shingrix Vaccine While On Prolia
This week were bringing you the another question submitted by our one of our clients and social media followers! If you have a question youd like to submit, please email us
Question:Can I have the Shingrix vaccine while on Prolia?
Answer:Prolia is a biologic medication used to treat osteoporosis. It is not a immunosuppressive treatment and any vaccine can be given while on Prolia. Shingrix is a non-live vaccine so not only is it safe to give with Prolia, it can be given while on other types of biologic therapies, such as those used to treat autoimmune diseases.
Carolyn Whiskin is the Pharmacy Manager for Charlton Health. Carolyn specializes in the treatment of autoimmune diseases, pharmaceutical compounding, womens health, pain and smoking cessation. Carolyn has won provincial and national awards for her commitment to patient care and public service.
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Carbamazepine Warfarin And Other Medicines Reported To Interact With The Influenza Vaccine
In recent years, New Zealand public health campaigns to encourage prophylaxis with influenza vaccines have targeted patient groups who are most at risk from influenza virus infection, such as people over 65 years of age or those with chronic diseases that impair infection response.1 The target group include patients taking a number of medicines.
Reports of patients developing phenytoin, warfarin or theophylline toxicity following influenza vaccination have been published.2–5 In one study, toxic elevations in levels of the concurrent medicines were reported to occur up to 28 days post-vaccination.5
Other cases of possible interactions include:
- A report received by the Australian Adverse Drug Reactions Advisory Committee of a 45-year-old female patient on long-term carbamazepine therapy for epilepsy, who developed carbamazepine toxicity following the administration of an influenza vaccine and
- A report received by Centre for Adverse Reactions Monitoring of a 70-year-old female patient taking long-term warfarin. Within a week of receiving an influenza vaccine, her INR was noted to be significantly elevated.
Is It Safe To Get Both Shots At Once
According to the CDC, current guidance has shown that COVID-19 vaccines can be coadministered with other vaccines, including influenza vaccines.
Lisa Grohskopf, MD, MPH, a medical officer in the influenza division at CDC, tells Verywell that while weve said recently when asked that its safe to get both vaccines, this is the first published notice.
The CDCs recommendation to give both shots at the same vaccine appointment is an update to previous guidance, which stated that people should wait 14 days between the COVID-19 and other vaccines.
According to the CDC, the guidance changed because experience with other vaccines has shown that the way our bodies develop protection, known as an immune response, after getting vaccinated and possible side effects of vaccines are generally the same when given alone or with other vaccines.
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Herpes Zoster In People Who Are Immunocompromised
People who are immunocompromised have an increased risk of herpes zoster compared with non-immunocompromised people. Rates of herpes zoster are up to 15 times higher in people who are immunocompromised due to HIV. In the 1st year after haematopoietic stem cell transplantation, up to 30% of patients may develop herpes zoster.25,37
Conjugate Vaccine Carrier Proteins
Protein conjugates used in Hib conjugate vaccines produced in the United States include tetanus toxoid which is also used as a component of DTaP and Tdap vaccines . Simultaneous or sequential vaccination with Hib and these tetanus-toxoid containing vaccines is recommended when both are indicated . MCV4 and PCV13 both contain diphtheria-toxoid conjugates. There has been concern about simultaneous administration of vaccines containing like conjugates. One brand of MCV4, MenACWY-D , demonstrates reduced immunogenicity of the antibody response to Streptococcal pneumonia strains when administered simultaneously with PCV13 compared with separate administration. It is recommended to space these vaccines by 28 days in a person with anatomic asplenia . Simultaneous or sequential vaccination of MCV4-CRM , PCV13, and Tdap , all of which contain diphtheria toxoid, is not associated with reduced immunogenicity or increase in local adverse events.
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Interchangeability Of Combination Vaccines From Different Manufacturers
Licensure of a vaccine by FDA does not necessarily indicate that the vaccine is interchangeable with products from other manufacturers. Such data are ascertained and interpreted more readily for diseases with known correlates of protective immunity . For diseases without such surrogate laboratory markers, prelicensure field vaccine efficacy trials or postlicensure surveillance generally are required to determine protection . ACIP prefers that doses of vaccine in a series come from the same manufacturer however, if this is not possible or if the manufacturer of doses given previously is unknown, providers should administer the vaccine that they have available.
Administration In People With Hiv
The product information for Zostavax states that the safety and efficacy of Zostavax have not been established in adults with known HIV infection with or without evidence of immunosuppression.
ATAGI recommends that Zostavax may be given to people who have HIV but are not immunocompromised, after confirming pre-existing immunity to varicella-zoster virus.
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How Long Does It Take To Work
Prolia can begin working right after your first dose. In fact, within only a few days after your Prolia dose, your body decreases its breakdown of bone.
And after about 1 month following your dose, Prolia is working at its maximum level to reduce bone loss and help increase your bone density.
You may not be able to tell that Prolia is working in your body. But during treatment, your doctor will order a test that measures your bone mineral density . This measurement shows how strong and dense your bones are. Your doctor will monitor your BMD to know whether or not Prolia is working for you.
Transporting Storing And Handling Vaccines
Transport according to National vaccine storage guidelines: Strive for 5.60 Store at +2°C to +8°C. Do not freeze. Protect from light.
Zostavax must be reconstituted. Add the entire contents of the diluent container to the vial and shake until the powder completely dissolves. Reconstitute immediately after taking the vaccine out of the refrigerator. Use the reconstituted vaccine within 30 minutes.
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Problems In The Jaw Bone
- Risk factors: Oral or dental procedures | Cancer diagnosis | Taking steroid medications or chemotherapy | Poor oral hygiene | History of dental diseases | Low red blood cell counts or clotting disorders | Infection | Wearing dentures that don’t fit well
Although it’s rare, Prolia can cause your jawbone to break down. This is more likely to happen if you’ve had dental procedures done while you’re taking the medication, if you have cancer, poor mouth hygiene, certain dental diseases, low red blood cell counts, blood clotting disorders, some sort of infection, if you wear dentures that don’t fit, if you take steroid medications, or if you’re getting chemotherapy. To lower your risk, practice good mouth hygiene, such as brushing and flossing your teeth multiple times per day. Your provider might suggest you have a dental exam before you start taking Prolia . If you notice pain or swelling in your jaw, talk to your provider right away. If you have a dental procedure planned while you’re taking this medication, let your provider know so you can discuss the risks and benefits of continuing this medication or having the procedure done.
Why Do Some Vaccines Interact With Medications
Vaccines work by creating an immune response in our bodies. This immune response does more than just create antibodies against a disease: It primes our bodies to fight an infection. Sometimes, these changes can affect how the cells in our bodies use the medications we take.
For example, some of the medications we take for other diseases are activated by an enzyme called cytochrome p450. Cytochrome p450 is a working molecule made by our bodies. It turns some medications on. It turns other medications off. We count on cytochrome p450 to work at a certain speed in order to get a steady response from our medications.
Strong inflammation, including the inflammation caused by severe COVID-19, puts this enzyme on hold. We dont know yet if the immune response caused by the vaccine could have a similar effect on cytochrome p450.
The good news is that most of the time, a small change in how quickly a medication is activated wont have any meaningful effect on your health. And the initial inflammation caused by the COVID-19 vaccine only lasts a few days. Once it goes down, your immune system will remember COVID-19, but the rest of your body will return to normal.
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Third Dose Of The Covid
A third dose of the Pfizer and Moderna vaccines has been approved for certain immunocompromised individuals, who may receive it at least 28 days after the second dose of the primary vaccine series. In this case, the extra shot is meant to give you additional initial protection if your immune system may not bolster a large response to just two shots .
Different Childhood Vaccines Can Be Given At The Same Time
Many vaccines are recommended early in life to protect young children from dangerous infectious diseases. In order to reduce the number of shots a child receives in a doctors visit, some vaccines are offered as combination vaccines. A combination vaccine is two or more different vaccines that have been combined into a single shot. Combination vaccines have been in use in the United States since the mid-1940s. Examples of combination vaccines are: DTap , trivalent IPV , MMR , DTap-Hib, and Hib-Hep B.
Often, more than one shot will be given during the same doctors visit, usually in separate limbs . For example, a baby might get DTaP in one arm or leg and IPV in another arm or leg during the same visit.
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